Table 1.
Study | Number of participants vaccinated in pregnancy | Country | Approach | Outcomes examined | Impact of COVID-19 vaccination | Ref. |
---|---|---|---|---|---|---|
v-safe pregnancy registry | 5,096 | United States | Registry | Stillbirth, preterm birth (PTB), small for gestational age (SGA), neonatal death, congenital abnormalities | None detected | 38 |
PTB, SGA, neonatal intensive care unit (NICU) admission, neonatal death, congenital abnormalities | None detected | 42 | ||||
Miscarriage | None detected | 43 | ||||
BORN Ontario | 64,234 | Canada | Registry | PTB, stillbirth, SGA | None detected | 44 |
Stock et al., 2022 | 18,399 | Scotland | Registry | PTB, perinatal death | None detected | 8 |
Bookstein-Peretz et al., 2021 | 390 | Israel | Registry | Miscarriage, PTB, SGA, NICU admission | None detected | 41 |
Norwegian National Health Registries | 1,003 | Norway | Case–control | Miscarriage | None detected | 47 |
Vaccine Safety Datalink | 31,080 | USA | Case–control | Stillbirth | None detected | 45 |
Miscarriage | None detected | 46 | ||||
Cohort | PTB, SGA | None detected | 48 | |||
Wainstock et al., 2021 | 913 | Israel | Cohort | PTB, pre-eclampsia, SGA | None detected | 49 |
Blakeway et al., 2021 | 140 | England | Cohort | PTB, stillbirth, SGA, NICU admission, congenital abnormalities | None detected | 51 |
Maccabi Healthcare Services | 24,288 | Israel | Cohort | Miscarriage, PTB, stillbirth, pre-eclampsia, SGA, SARS-CoV-2 infection | Reduced risk of SARS-CoV-2 infection | 52 |
Cohort | PTB, SGA, congenital abnormalities, death and hospitalization of infants up to 6 months old | None detected | 50 | |||
Theiler et al., 2021 | 140 | United States | Cohort | PTB, stillbirth, pre-eclampsia, SGA, NICU admission, SARS-CoV-2 infection | Reduced risk of SARS-CoV-2 infection | 53 |
UK Health Security Agency | 58,165 | United Kingdom | Cohort | PTB, stillbirth, SGA | None detected | 54 |
Results from the 12 studies summarized show no increased risk of any poor obstetric outcome associated with COVID-19 vaccination. The total number of participants included in these studies is 185,309. This has been calculated as the sum of all participants, except for those in Blakeway et al.51 and Stock et al.8, who are also included in the UK Health Security Agency data and would otherwise be counted twice.